BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 20400227 · Received October 8, 2024

    Report

    Report Number
    1722028-2024-00433
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    February 14, 2023
    Report Date
    October 8, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. CITATION: ÖZKAYA, P. Y., KOÇ, G., ERSAYOGLU, I., CEBECI, K., ÖZDEMIR, H. H., KARADAS, N., KARAPINAR, D. Y., & KARAPINAR, B. (2024). THERAPEUTIC PLASMA EXCHANGE IN CRITICALLY ILL CHILDREN: A SINGLE CENTER EXPERIENCE. THERAPEUTIC APHERESIS AND DIALYSIS. HTTPS://DOI.ORG/10.1111/1744-9987.14141 FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. THERE WAS NO ALLEGED MEDICAL INTERVENTION AGAINST A TBCT DEVICE. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. CITATION: ZKAYA, P. Y., KO, G., ERSAYO LU., CEBECI, K., ZDEMIR, H. H., KARADAS, N., KARAPINAR, D. Y., & KARAPINAR, B. (2024). THERAPEUTIC PLASMA EXCHANGE IN CRITICALLY ILL CHILDREN: A SINGLE CENTER EXPERIENCE. THERAPEUTIC APHERESIS AND DIALYSIS. HTTPS://DOI.ORG/10.1111/1744-9987.14141. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN CRITICALLY ILL CHILDREN: A SINGLE CENTER EXPERIENCE" BY YAZICI OZKAYA, P., KOÇ, G., ERSAYOGLU, I., CEBECI, K., HEKIMCI OZDEMIR, H., KARADAS, N., YILMAZ KARAPINAR, D., KARAPINAR, B.. POTENTIAL ADVERSE EVENT : ADVERSE EVENTS WERE OBSERVED IN 68 (13.9%) SESSIONS.HYPOTENSION (7.8%) AND HYPOCALCEMIA (5.1%) WERE THET A B L E 1 INDICATIONS FOR THERAPEUTIC PLASMA EXCHANGE AND DISEASE CATEGORY.CLINICAL DIAGNOSIS PATIENTS (%) (N = 154) NUMBER OF TPE SESSIONS (N = 486) ASFA CATEGORYSEPSIS WITH MULTIORGAN DYSFUNCTION SYNDROME 42 (27.3) 104SEPSIS + PREVIOUSLY HEALTHY 15 (9.7) 34 IIISEPSIS + CO-MORBIDITY 27 (17.6) 70 IIIHEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS 14 (9.1) 49 IIILIVER DISEASES 48 (31.2) 148ACUTE LIVER FAILURE 43 (28) 127 IIIWILSON DISEASE 5 (3.2) 21 IRHEUMATOLOGICAL DISEASES 4 (2.6) 34SYSTEMIC LUPUS ERYTHEMATOSUS 3 (1.9) 30 IIGRANULOMATOSIS WITH POLYANGIITIS (GPA) 1 (0.7) 4 IIITHROMBOTIC MICROANGIOPATHY 15 (9.7) 68COMPLEMENT MEDIATED 10 (6.5) 45 IIIINFECTION MEDIATED (STEC HUS) 1 (0.6) 5 IIITMA, TRANSPLANTATION ASSOCIATED 2 (1.3) 8 IIITHROMBOTIC THROMBOCYTOPENIC PURPURA 2 (1.3) 10 IPOISONING 21 (13.6) 37MUSHROOM POISONING 11 (7.1) 25 IIDRUG POISONING 10 (6.5) 17 IIINEUROLOGICAL DISEASES 10 (6.5) 46ADEM 3 (1.9) 21 IINMDA RECEPTOR ANTIBODY ENCEPHALITIS 1 (0.6) 10 IACUTE INFLAMMATORY DEMYELINATINGPOLYRADICULONEUROPATHY5 (3.2) 18 IMULTIPLE SCLEROSIS 1 (0.6) 2 IIABBREVIATIONS: ADEM, ACUTE DISSEMINATED ENCEPHALOMYELITIS; ASFA, AMERICAN SOCIETY FOR APHERESIS; HUS, HEMOLYTIC UREMIC SYNDROME; NMDA, N-METHYL-D-ASPARTATE RECEPTOR ANTIBODY ENCEPHALITIS; STEC, SHIGA TOXIN-PRODUCING ESCHERICHIA COLI; TMA, THROMBOTIC MICROANGIOPATHY; TPE, THERAPEUTIC PLASMAEXCHANGE.YAZICI ÖZKAYA ET AL . 795MOST FREQUENT ADVERSE EVENTS FOLLOWED BY ARRYTHMIA(11.2%), ALLERGIC REACTION (11.2%), AND TRANSFUSION RELATED-ACUTE LUNG INJURY (0.2%). NONE OF THE PATIENT COMPLICA-TIONS RESULTED IN PREMATURE DISCONTINUATION OF THE PROCE-DURE. CATHETER MALFUNCTION WAS OBSERVED IN 14 SESSIONS(2.8%). THE OCCURRENCE OF CATHETER RELATED PROBLEMS WASSIGNIFICANTLY ASSOCIATED WITH A LOWER WEIGHT (39.6% FOR<10 KG CHILDREN, 25.1% FOR >10 KG CHILDREN, P = 0.005).THERE WAS NO MORTALITY SECONDARY TO TPE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN CRITICALLY ILL CHILDREN: A SINGLE CENTER EXPERIENCE" BY YAZICI OZKAYA, P., KO¿¿, G., ERSAYO¿¿LU, ¿¿., CEBECI, K., HEKIMCI OZDEMIR, H., KARADAS, N., YILMAZ KARAPINAR, D., KARAPINAR, B.. POTENTIAL ADVERSE EVENT : ADVERSE EVENTS WERE OBSERVED IN 68 (13.9%) SESSIONS.HYPOTENSION (7.8%) AND HYPOCALCEMIA (5.1%) WERE THET A B L E 1 INDICATIONS FOR THERAPEUTIC PLASMA EXCHANGE AND DISEASE CATEGORY.CLINICAL DIAGNOSIS PATIENTS (%) (N = 154) NUMBER OF TPE SESSIONS (N = 486) ASFA CATEGORYSEPSIS WITH MULTIORGAN DYSFUNCTION SYNDROME 42 (27.3) 104SEPSIS + PREVIOUSLY HEALTHY 15 (9.7) 34 IIISEPSIS + CO-MORBIDITY 27 (17.6) 70 IIIHEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS 14 (9.1) 49 IIILIVER DISEASES 48 (31.2) 148ACUTE LIVER FAILURE 43 (28) 127 IIIWILSON DISEASE 5 (3.2) 21 IRHEUMATOLOGICAL DISEASES 4 (2.6) 34SYSTEMIC LUPUS ERYTHEMATOSUS 3 (1.9) 30 IIGRANULOMATOSIS WITH POLYANGIITIS (GPA) 1 (0.7) 4 IIITHROMBOTIC MICROANGIOPATHY 15 (9.7) 68COMPLEMENT MEDIATED 10 (6.5) 45 IIIINFECTION MEDIATED (STEC HUS) 1 (0.6) 5 IIITMA, TRANSPLANTATION ASSOCIATED 2 (1.3) 8 IIITHROMBOTIC THROMBOCYTOPENIC PURPURA 2 (1.3) 10 IPOISONING 21 (13.6) 37MUSHROOM POISONING 11 (7.1) 25 IIDRUG POISONING 10 (6.5) 17 IIINEUROLOGICAL DISEASES 10 (6.5) 46ADEM 3 (1.9) 21 IINMDA RECEPTOR ANTIBODY ENCEPHALITIS 1 (0.6) 10 IACUTE INFLAMMATORY DEMYELINATINGPOLYRADICULONEUROPATHY5 (3.2) 18 IMULTIPLE SCLEROSIS 1 (0.6) 2 IIABBREVIATIONS: ADEM, ACUTE DISSEMINATED ENCEPHALOMYELITIS; ASFA, AMERICAN SOCIETY FOR APHERESIS; HUS, HEMOLYTIC UREMIC SYNDROME; NMDA, N-METHYL-D-ASPARTATE RECEPTOR ANTIBODY ENCEPHALITIS; STEC, SHIGA TOXIN-PRODUCING ESCHERICHIA COLI; TMA, THROMBOTIC MICROANGIOPATHY; TPE, THERAPEUTIC PLASMAEXCHANGE.YAZICI ¿¿ZKAYA ET AL . 795MOST FREQUENT ADVERSE EVENTS FOLLOWED BY ARRYTHMIA(11.2%), ALLERGIC REACTION (11.2%), AND TRANSFUSION RELATED-ACUTE LUNG INJURY (0.2%). NONE OF THE PATIENT COMPLICA-TIONS RESULTED IN PREMATURE DISCONTINUATION OF THE PROCE-DURE. CATHETER MALFUNCTION WAS OBSERVED IN 14 SESSIONS(2.8%). THE OCCURRENCE OF CATHETER RELATED PROBLEMS WASSIGNIFICANTLY ASSOCIATED WITH A LOWER WEIGHT (39.6% FOR¿¿¿10 KG CHILDREN, 25.1% FOR ¿¿¿10 KG CHILDREN, P = 0.005).THERE WAS NO MORTALITY SECONDARY TO TPE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685543 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other